Pharmacy Practice: Controlled Substances

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Questions and Answers

What is the main reason for the government control of certain substances?

Because they may be abused or cause addiction (correct)

Because they are expensive

Because they are only available by prescription

Because they are only used in hospitals

What is the responsibility of the Division of controlled drugs, DRAP?

To manufacture controlled substances

To dispense controlled substances to patients

To regulate and allocate quota of narcotic drugs (correct)

To prescribe controlled substances to patients

How many categories of controlled substances are there?

Five

Four

Three (correct)

Two

What are controlled substances with known medical use available by?

Prescription from a licensed medical professional Signup and view all the answers

Which of the following is NOT a category of controlled substances?

Antibiotics Signup and view all the answers

What is the name of the law that regulates controlled substances used as medicines?

Drugs Act, 1976 Signup and view all the answers

What is the purpose of the UN Conventions?

To regulate the use of chemical entities with therapeutic uses Signup and view all the answers

What is the primary function of the Ministry of Narcotics Control?

To regulate and allocate quota of narcotic drugs Signup and view all the answers

What is the name of the agency responsible for regulating and allocating the quota of controlled substances?

DRAP Signup and view all the answers

What is the primary focus of the Controlled Substances management system?

Secure storage and handling of controlled substances Signup and view all the answers

What is the preferred method of manual documentation for controlled substances?

Using indelible ink Signup and view all the answers

What is the purpose of having a clear chain of signatures in controlled substance records?

To show the transfer of responsibility at each transition point Signup and view all the answers

What is a key principle of successful inventory management?

Maintaining accountability and sign-offs by authorized staff at all transition points Signup and view all the answers

Why is it important to keep quantities of controlled substances to a minimum?

To minimize the risk of error or diversion Signup and view all the answers

What should be considered when determining the drug needs of a healthcare facility or patient care area?

Medical conditions, local protocols, drug formulary, and utilization patterns Signup and view all the answers

Who should handle, prescribe, or have access to controlled substances?

Authorized staff only Signup and view all the answers

Where should controlled substances be stored?

In a locked room, cart, or fridge Signup and view all the answers

Why should inventory levels be periodically reviewed?

To identify changes in utilization trends and clinical practice Signup and view all the answers

What is a goal of inventory management?

Maintaining the lowest amount of inventory possible while ensuring reasonable and timely access Signup and view all the answers

What is the purpose of accounting for all keys at all times?

To prevent unauthorized access to controlled substances Signup and view all the answers

Who should supply a hospital with a controlled substance?

A licensed dealer Signup and view all the answers

What is the purpose of setting up systems to uniquely identify each user?

To ensure that each transaction can be traced to a user Signup and view all the answers

What is the benefit of accurate and complete records of controlled substance transactions?

All of the above Signup and view all the answers

What should be minimized in the procurement process?

Manual ordering Signup and view all the answers

Why is it important to maintain secure storage?

To prevent misuse or diversion of controlled substances Signup and view all the answers

What should be assessed during inventory reviews?

Minimum and maximum stock levels, changes in utilization trends, and clinical practice Signup and view all the answers

Why is it important to consider travel time between receiving department, pharmacy, care units, and other sites?

To ensure timely access to controlled substances Signup and view all the answers

When using a manual procurement process, what should be done with the forms used to purchase controlled substances?

Prenumber them sequentially and closely control them using a log Signup and view all the answers

What should be ensured when storing controlled substances in the pharmacy department?

Physical security, adherence to recommended storage conditions, and meeting relevant standards Signup and view all the answers

Who should have access to controlled substances or the areas where they are stored?

Only designated pharmacy staff Signup and view all the answers

Why is a two-key system desirable in patient care areas?

For security and medication control Signup and view all the answers

What should be done with controlled substances in locked drawers in medication carts?

Never leave them unattended Signup and view all the answers

What is required for each formulation and container type of controlled substances?

A separate record within the perpetual inventory Signup and view all the answers

What happens when a controlled substance is manipulated or repackaged?

A new inventory record is created Signup and view all the answers

What should be used to order controlled substances in an electronic procurement process?

A unique access code Signup and view all the answers

Why should blank purchase orders or requisitions for controlled substances not be pre-signed or left unsecured?

To prevent unauthorized access Signup and view all the answers

What information should be included in the pharmacy record for each medication movement?

Date, time of issue, patient care area, drug name, strength, and dosage form Signup and view all the answers

Who is responsible for the proper safeguarding and handling of controlled substances in the hospital?

Administrator Signup and view all the answers

What should accompany each request for a new supply of controlled substances?

A controlled drug administration form Signup and view all the answers

Who can write a prescription for a controlled drug?

Licensed physician or registered resident Signup and view all the answers

What should happen to a prescription for a controlled drug after it has been fulfilled?

It is retained for records Signup and view all the answers

What should be done during every shift change regarding controlled substances?

The controlled substances are audited for count and use Signup and view all the answers

What should be done if a discrepancy is found in the controlled substances during a shift change?

The discrepancy is reported to the pharmacy Signup and view all the answers

What is required for personnel involved in research using controlled substances?

They must be registered under DRAP rules Signup and view all the answers

What records must be kept by personnel involved in research using controlled substances?

Receipt records, dispensing records, and administration records Signup and view all the answers

Study Notes

Controlled Substances

A drug or substance tightly controlled by the government due to its potential for abuse or addiction.
Control applies to its manufacture, use, handling, storage, and distribution.
Examples include opioids, stimulants, depressants, hallucinogens, and anabolic steroids.

Regulation of Controlled Substances

Laws: DRAP Act, 2012, Drugs Act, 1976, and Control of Narcotic Substances (CNS) Act, 1997.
Division of controlled drugs: DRAP in consultation with the Ministry of Narcotics Control is responsible for regulation and allocation of quota of narcotic drugs, psychotropic substances, and precursor chemicals.

Categories of Controlled Substances

Narcotic Drugs
Psychotropic Substances
Precursor Chemicals

Distribution of Controlled Substances

Fundamentals:
- Securely stored and handled throughout the medication management system.
- Accurate and complete records of all transactions maintained in a timely manner.
- All manual documentation is made in indelible ink.
- Clear chain of signatures showing transfer of responsibility at each transition point.
- Records can be easily audited.
Principles:
- Quantities kept to the minimum needed according to patient population and degree of urgency.
- Authorized staff handle, prescribe, or have access to controlled substances.
- Stored in restricted areas, such as locked rooms, carts, or fridges.
- All keys are accounted for at all times.
- Systems set up to ensure each user is uniquely identified and every transaction can be traced.

Inventory Management

Key principles:
- Keeping stock secure at all times.
- Maintaining accountability and sign-offs by authorized staff at all transition points.
- Checking for completeness of an order and integrity of the product at all transition points.
Consideration should be given to maintaining the lowest amount of inventory possible while ensuring reasonable and timely access.
Factors to consider when determining drug needs:
- Medical conditions being treated.
- Local protocols, pathways, and care maps.
- Drug formulary and formulary policies.
- Utilization and prescribing patterns.
- Range of dosing (e.g., pediatric vs adult care; acute vs chronic pain management).
- Availability and capacity of secure storage.
- Travel time between receiving department, pharmacy, care units, and other sites.

Procurement

Licensed dealer (e.g., manufacturer or distributor) shall supply a hospital with a controlled substance.
Manual Procurement Process:
- Manual ordering should be minimized.
- Forms used to purchase controlled substances should be sequentially prenumbered and closely controlled using a log.
- Under no circumstances should blank purchase orders or requisitions for controlled substances be pre-signed or left unsecured.
Electronic Procurement Process:
- Only restricted to individual authorized users.
- Should have unique access code to order controlled substances.

Storage

Controlled substances maintained in the pharmacy department should be stored:
- In a manner that ensures their physical security.
- Adhering to the recommended storage conditions for the drug.
- Meeting relevant standards (e.g., from accreditation or regulatory authorities).
Access to controlled substances or areas where they are stored should be further limited to designated pharmacy staff.

Storage in Patient Care Areas

Should use a double or triple lock procedure.
The medication room door and the locked cupboard should never have the same lock.
Alternatively, controlled substances may be stored in locked drawers in medication carts used to deliver the drugs to patients but it should never be left unattended.

Dispensing

Each formulation and container type should have a separate record within the perpetual inventory.
For each medication movement, the pharmacy record should include:
- Date.
- Time of issue.
- Patient care area.
- Drug name, strength, and dosage form.
- Quantity delivered or returned.
- Names and signatures of pharmacy and patient care area staff involved.

Model Set of Hospital Control Procedures

Responsibility for controlled drug substances in hospital:
- Administrator is responsible for the proper safeguarding and handling of controlled substances.
- Pharmacist in chief is responsible for purchase, storage, accountability, and proper dispensing of controlled substances.
- Registers must be maintained for dispensing of controlled substances.
Ward stock for controlled substances:
- Stock is replaced by duly signed sheet and provision of empty vials.
- Each request for new supply is accompanied by a controlled drug administration form.
- For any drug that is lost or wasted, the nurse in charge must prepare an incident form.

Doctor's Order for Administration of Controlled Drug

Duly signed by physician in non-edible ink.
Prescription can only be written by licensed and authorized physician or registered resident.

Miscellaneous Regulations

Ward supplies of controlled medicines should only be used for patients on the ward.
Narcotic prescriptions are not refilled.
Prescription is retained for records.
Physician may not prescribe narcotics for personal use.

Control of Narcotics by Nurses

Narcotics are audited for count and use in every shift change.
Every shift has a designated nurse for narcotics control.
Both the nursing staff from new and old shift sign the records.
If discrepancy found, it should be reported to the pharmacy.

Research Use

Personnel involved in research are to be registered under DRAP rules.
If there are more than one location, each location has to be registered separately.
Each personnel has to keep records of research and controlled substance used, including:
- Receipt records.
- Dispensing records.
- Administration records.

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Description

This quiz covers controlled substances, laws applicable to them, and their distribution and dispensing in hospital pharmacy practice. It is designed for PharmD students.